Shipping Validation Specalist
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a Shipping Validation Specialist to be part of our client’ s team in the Fremont area. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Process Validation Specialist :
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Execute shipping/transport (protocol generation and execution) validation activities related to the implementation of system changes and new systems, in accordance with defined procedures and in alignment with Health Authority requirements.
- Employ good document practices (GDP) when recording data, executing protocols, and drafting and reviewing documents.
- Participates in identifying best practices in support of risk-based verification and qualification for shipping systems.
- Maintain current knowledge of industry standards and regulatory requirements for shipping of products and develop validation techniques/approaches.
- Generation of protocols with validation strategy taking in to account various routes, shippers, loads etc using risk based and worst case approaches.
- Responsible for creating, reviewing or approving quality documents: including System Requirements (URS), gap assessments, validation protocols, and reports as necessary.
- Coordinate validation activities involving cross functional, multi-departmental teams including: Supply Chain, Quality Control, Quality Assurance, Manufacturing, MSAT and various Engineering groups.
- Familiarity and understanding of shipping simulation studies required per ASTM D4169.
Summary of Qualifications:
- A minimum of Bachelor' s Degree with Science or Engineering. 6 Years of experience in pharmaceutical industry with a minimum of 4 years in validations.
- Excellent technical writing and verbal communication skills
- Ability to work as part of a high performing team and collaborate effectively with staff at all levels.
- Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
- Demonstrated ability to manage multiple activities while maintaining a high level of organization.
- Must have a strong understanding of validation principles.
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
- Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
- Ability to interpret and relate Validation standards for implementation and review to functional areas.
- Demonstrate flexibility in problem solving, providing risk-based options towards challenges for management review and decision making.
- Develop and maintain effective communication with peers, subordinates and senior management.
- Actively participate in technical, tactical and strategic reviews/discussions.
- Remain current on all training requirements.
- Work collaboratively with project teams.